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RecruitingAccepts healthy volunteersPhase 4

Post-Prandial Carbohydrate Metabolism in Individuals With and Without Post-Bariatric Surgery Hypoglycemia (PBH)

Joslin Diabetes Center · with University of Alabama at Birmingham, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NCT07818707

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–70 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 4
Target enrollment
40
US sites recruiting
2
Study start
January 27, 2026
Record last updated
September 14, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

In this study, the investigators will determine (a) whether metabolism (secretion and turnover) of glucagon is altered in patients with PBH, (b) whether this is affected by a meal, (c) whether PBH affects the ability of the body to produce glucose (endogenous glucose production), and (d) whether PBH affects the amount of glycogen in the liver (storage form of glucose) when fasting and after a meal. The investigators will determine the effect of glucagon to raise glucose levels after a meal. To answer these questions, participants will receive an infusion of a stable (nonradioactive) isotope of glucose and glucagon, and a meal containing a stable isotope of glucose. Glycogen will be measured by magnetic resonance imaging (MRI) of the liver before and after the meal. This information will be used to develop computer models for the glucagon pump system.

Being studied: Glucagon for Injection (Fresenius Kabi USA); [6,6-2H2] glucose; [13C9, 15N1]-glucagon; [1-13C] glucose; [2-13C] glucose

Conditions: Hypoglycemia; Hypoglycemia, Reactive; Bariatric Surgery

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

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Inclusion Criteria

  • Age 18-70 years of age, inclusive, at screening.
  • Willingness to provide informed consent and follow all study procedures, including attending all scheduled visits.
  • Males or females at least 2 years following Roux-en-Y gastric bypass (RYGB)
  • For patients recruited to PBH group: diagnosed with ongoing PBH, with documented episodes of hypoglycemia, and history of fulfillment of Whipple's triad.

Exclusion Criteria

  • Documented hypoglycemia occurring only in the fasting state (>12 hours fast);
  • Current diabetes, defined as hemoglobin A1c >6.5% or use of diabetes medications, except for acarbose or miglitol;
  • Chronic kidney disease stage 4 or 5 (including end-stage renal disease);
  • Hepatic disease, including serum ALT or AST greater than 2 times the upper limit of normal; hepatic synthetic insufficiency as defined as serum albumin \< 3.0 g/dL; or serum bilirubin > 2.0;
  • Congestive heart failure, NYHA class II, III or IV;
  • History of myocardial infarction, unstable angina or revascularization within the past 6 months.
  • Two or more risk factors for coronary artery disease including diabetes, uncontrolled hypertension, uncontrolled hyperlipidemia, and active tobacco use.
  • History of recurrent syncope (unrelated to hypoglycemia) or active diagnosis of a cardiac arrhythmia;
  • Current administration of β-blocker therapy;
  • History of a cerebrovascular accident;
  • Seizure disorder (other than with suspect or documented hypoglycemia);
  • Active treatment with long-acting (LAR) octreotide or pasireotide;
  • Active malignancy, except basal cell or squamous cell skin cancers;
  • Personal or family history of pheochromocytoma or disorder with increased risk of pheochromocytoma (MEN 2, neurofibromatosis, or Von Hippel-Lindau disease);
  • Known insulinoma;
  • Major surgical operation within 30 days prior to screening;
  • Clinically significant anemia as defined as a hematocrit \< 33%;
  • Bleeding disorder, treatment with warfarin, or platelet count \<50,000;
  • Blood donation (1 pint of whole blood) within the past 2 months;
  • Active alcohol abuse or substance abuse;
  • Current administration of oral or parenteral corticosteroids;
  • Pregnancy and/ or lactation: For persons of childbearing potential: there is a requirement for a negative urine pregnancy test before any procedures.
  • Not enrolled in another study that uses an investigational drug for this condition.

Recruiting US locations

  • University of Alabama

    Birmingham, AL 35294

    Site contact: Ananda Basu, MD · 205-975-0471 · anandabasu@uabmc.edu

  • Joslin Diabetes Center

    Boston, MA 02215

    Site contact: Mary-Elizabeth Patti, MD · 617-309-2400 · mary.elizabeth.patti@joslin.harvard.edu

Post-Prandial Carbohydrate Metabolism in Individuals With and… (NCT07818707) | Bored Studies